MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) and US-based Xencor, Inc. today announced the successful completion of patient enrollment in the phase 1 clinical trial evaluating MOR208. MOR208 (formerly XmAb®5574) is a potent anti-CD19 antibody with a proprietary modification to the Fc portion, that is being developed to treat B-cell malignancies. A total of 30 patients with relapsed or refractory chronic lymphocytic leukemia (CLL/SLL) have been randomized in the open-label, multi-dose, single-arm, dose-escalation study. No dose-limiting toxicity was observed and the trial protocol was amended to include a period of extended dosing for patients responding to treatment. The phase 1 trial was designed to assess the drug's safety, tolerability, pharmacokinetic profile and preliminary anti-tumor activity. Data from the trial will become available in Q4 2012.
"We are excited about the excellent progress of the MOR208 program and are preparing the next steps of clinical development in additional B-cell malignancies to quickly assess the broader commercial potential of the molecule," commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG. "The extended treatment period we were able to include in the phase 1 study could provide us with additional data on preliminary anti-tumor activity."
"MOR208 uses our XmAb ADCC technology to enhance its B-cell depletion properties," said Bassil Dahiyat, Ph.D., Chief Executive Officer of Xencor. "The XmAb high ADCC technology has been applied to develop six antibodies that are now in clinical testing, demonstrating the technology's broad applicability."